Bharat Biotech submits Covaxin phase 3 trials data to DCGI: Reports - Hindustan Times

Source: Hindustan Times

Bharat Biotech, the Hyderabad-based drugmaker which has developed India's only indigenous shot against the coronavirus disease (Covid-19), Covaxin, has submitted data from phase 3 trials of the vaccine to the Drugs Controller General of India (DCGI), according to news agency ANI.Also Read | Final analysis to be public soon: Bharat Biotech on Phase III trialdata"We've received the data from phase 3 trials," ANI quoted a senior government official as saying. Also, according to reports, the Subject Expert Committee (SEC) is likely to meet on Tuesday to review the phase 3 data.The reported development comes amid a controversy over data from the third stage trials of Covaxin which Bharat Biotech earlier said it would make public in June, only to announce later that the data would, in fact, be made public in July, a delay of about a month from the originally announced timeline.

Also Read | Covaxin phase 3 trial results to be out in July: Bharat BiotechCovaxin is among three vaccines being used in the nationwide drive against Covid-19. It was granted approval by the DCGI in January, along with the Oxford University-AstraZeneca shot which is being manufactured locally by the Pune-based Serum Institute of India (SII) as Covishield. A third vaccine, Russia's Sputnik V, was granted emergency use authorisation (EUA) in April.The vaccination drive against the coronavirus disease began on January 16. However, since the beginning, doubts have been raised on Covaxin's efficacy as the vaccine was granted EUA without the completion of its third stage trials.
Interim data released by Bharat Biotech in April showed that the shot was 78% effective against symptomatic disease and 100% against serious illness.Last week, Bharat Biotech refuted rumours it had submitted phase 3 data to the World Health Organization's (WHO) for the global health body's approval, calling such reports "incorrect and lacking any evidence." Reports claimed WHO would review Bharat Biotech's application on June 23.